The Effect of the Treatment Environment on Pain, Function, Self Efficacy and Satisfaction in RCRSP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient Education, Exercise Therapy, Cold Application.
- Who it may be relevant to
- Registry conditions: Shoulder Pain, Subacromial Pain Syndrome, Rotator Cuff Syndrome of Shoulder and Allied Disorders. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of the Treatment Environment on Pain, Function, Self Efficacy and Satisfaction in Rotator Cuff Related Shoulder Pain
Overview
Brief Summary The aim of this randomized controlled study is to reveal the short-term effects of physical and social factors in different therapeutic environments on patients with rotator cuff related shoulder pain following the same exercise program. The main questions it aims answer are: * Is there any difference in terms of pain levels among groups with rotator cuff related shoulder pain who treated in different therapeutic settings. * Is there any difference in terms of functionality and self-efficacy among groups with rotator cuff related shoulder pain who treated in different therapeutic settings.
Detailed description
The investigators will include patients who applied to the physiotherapy clinic of Kadikoy Florence Nightingale Medical Center with the complaint of shoulder pain. 46 individuals who volunteer to participate in the study will be included. Participants will be randomised through a computer-based randomization program into two groups; the enriched therapeutic environment group (Group 1) and the isolated therapeutic environment group (Group 2). The same treatment including patient education, exercise therapy and ice application will be performed to both groups. Participants will receive a total of 15 sessions of treatment, 3 sessions per week. Before the treatment, 3rd week, 6th week and 12th week, the following evaluations will be made to both groups; Numerical Pain Rating Scale (NPRS) to asses pain, Arm, Shoulder, Hand Problems Quick Survey (Quick-DASH) and Western Ontario Rotator Cuff Index (WORC) to asses functionality, Pain Self-Efficacy Questionnaire (PSEQ) to asses self efficacy and Global Scale of Change (GRC) to asses the effectiveness of the treatment.
Interventions
- Behavioral Patient Education
It includes evaluation of the treatment process and past sessions. Simple shoulder biomechanics, function, and what caused the injury were explained to the patients. In order to increase patients' participation in treatment, it was emphasized what the treatment does and that the patient should cooperate in order to heal. During their treatment, patients are instructed to regulate their daily living activities, avoid overhead and repetitive movements of the arm, bags weighing more than 2-3 kg, et - Behavioral Exercise Therapy
Participants in both groups were included in a structured exercise program consisting of exercises recommended in the literature. This exercise program includes joint range of motion exercises, stretching exercises and strengthening exercises and was carried out under the supervision of a physiotherapist for 6 weeks. Joint range of motion and strengthening exercises are recommended as 3 sets of 10 repetitions, and stretching exercises are recommended as 5 repetitions for 20 seconds. Exercises ap - Behavioral Cold Application
Following each exercise treatment, cold-pack will be applied for 15 minutes. During col-pack application, patients in the Group 1 group will listen to classical music selected by us, while patients in the Group 2 will rest quietly. There are a total of 40 songs by Bach, Mozart, Beethoven and Andre Rieu on our CD player, and patients have the right to choose and listen to the song they want.
Primary outcome measures
- Numeric Pain Rating Scale (NPRS) [Time frame: Baseline, 3rd week, 6th week]
Secondary outcome measures (4)
- Quick - The Disabilities of the Arm, Shoulder and Hand (Quick DASH) Questionnaire [Time frame: Baseline, 3rd week, 6th week, 12th week]
- Western Ontario Rotator Cuff (WORC) Index [Time frame: Baseline, 3rd week, 6th week, 12th week]
- Pain Self-Efficacy Questionnaire (PSEQ) [Time frame: Baseline, 3rd week, 6th week, 12th week]
- Global Rating of Change, GRC [Time frame: Baseline, 3rd week, 6th week, 12th week]
Eligibility criteria
Inclusion criteria
- 18-75 years old
- diagnosed with impingement syndrome, subacromial bursitis, rotator cuff tendinopathy or partial rotator cuff tear
- pain level between 3-7 according to visual analog scale
- pain persisted for at least 3 months
Exclusion criteria
- having a full-thickness or massive rotator cuff tear
- history of shoulder surgery
- having a musculoskeletal disease that prevents exercise
- having a neurological disease or psychological disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- İstanbul University Cerrahpasa Faculty of Health Sciences — Istanbul
Identifiers
NCT: NCT06449534 · 2150060